The heads of the CMS and the Food and Drug Administration want universal health insurance claims forms to include unique device identifiers. The UDI would improve post-market surveillance and provide for better value-based reimbursement based on device performance, they say.
CMS Administrator Andy Slavitt and FDA Commissioner Dr. Robert Califf wrote Wednesday (PDF) to the chair of the Accredited Standards Committee X12, or ASC X12, to ask that the organization add UDIs for implantable medical devices on claims forms. The letter reflects the FDA's push to improve device evaluation and surveillance, as outlined in a JAMA editorial Monday co-written by Califf.
Proponents of the use of UDIs say they could more quickly identify dangerous devices, some of which in recent years have not been flagged until they hurt patients. Those pushing for the use in claims say they could inform population health by evaluating associated outcome data.
Manufacturers and distributors currently are implementing UDIs and electronic health records are being tweaked to allow providers to one day record unique device identifiers, but insurance claims forms had been the holdout. Some in the industry say the changes are costly because the technology to support the changes isn't there.
The letter addresses the group that sets standards for sharing data gathered and used by the insurance industry, as well as other industries. The group's steering committee is chaired by Gary Beatty, an executive at UnitedHealthcare.
ASC X12 will release the next version of the insurance claims form for public comment in December. That template will be released in 2021. The next update isn't scheduled for another 10 years.
In its request, the CMS is somewhat stepping back from its previous stance on the issue. In May, Slavitt testified before Congress that the UDI inclusion would require funding and training, but expressed optimism for implementing the move.
In Wednesday's letter, Slavitt and Califf say UDIs in claims have cost benefits because they would help providers and payers calculate and compare total spending and outcomes and provide better data to track manufacturer rebates owed to the payer or provider.
The two wrote that HHS supports the idea "if sufficient funding and resources are provided to make the necessary Medicare claims processing system changes.” They acknowledge that including the UDI will be complex and require a change in workflow and systems for providers and billing companies, but say they're committed to a plan that minimizes impact on state Medicaid agencies, health plans, small physician practices and rural hospitals.
Last year, the CMS's Office of Inspector General said that UDIs could save the agency money and offer insights into population health.
Although it's been suggested that including the UDI in claims could be more important than including it in the EHR, the American Hospital Association is adamant that supply chain and clinical professionals be able to document the devices since they are the ones first in contact with them.
“The claim is generally the last operational piece that gets completed and it is vitally important that the other steps get done first,” said Ashley Thompson, the organizations' senior vice president for public policy analysis and development, in a recent statement.
Zach Rothstein, associate vice president of technology and regulatory affairs for Advanced Medical Technology Association, the Washington-based lobby for medical-device manufacturers, said the organization would like to see more research into whether UDIs actually improve post-market surveillance.
Slavitt has previously testified that putting UDIs into the EHR should be the top priority. And that is likely to happen. EHR vendors expect to offer software with UDI capture capabilities by 2018.
Thirty-five organizations, including providers, physician societies, patient advocacy groups, data standard organizations, group purchasing organization Premier and health insurer Aetna have backed the use of UDI in claims, citing quality and safety.
The Pew Charitable Trusts has been advocating for regulators to take action soon to avoid the long delay before the next update to the forms, said Ben Moscovitch, medical devices officer at Pew.
“Claims provide population health benefits,” Moscovitch said. “Because they're standardized across the industry, they can be more easily aggregated to understand outcomes associated with a particular procedure over time.”
Advocates at Pew say the move could augment the benefits of the FDA's Sentinel post-market surveillance program, which relies predominately on claims data. Adding UDI to claims would allow Sentinel to conduct large, longitudinal analyses on device safety, according to Pew.
Dr. Josh Rising, Pew's director of healthcare programs, said that claims information can track patients' long-term outcomes and the device's impact on health.
Rising also noted that Medicare and other payers could benefit from being able to alert their customers to device malfunctions, and pointed to recent malfunctions with metal-on-metal hips, implantable defibrillator leads and surgical mesh as examples of recent delays in discovering issues.
“Claims data follows patients across the health system. Even if we put it in the electronic health record, if they go to a different physician ... it doesn't (necessarily) go to the other physician,” said Dr. James Rickert, an orthopedic surgeon at Indiana University Health, Wilmington, and a member of the National Physician Alliance's FDA task force. The UDI will eventually be tracked via patient care summaries available to physicians through the EHR.
The National Physician Alliance, a patient advocacy group, wants the FDA to make public de-identified claims information that includes UDIs and associated health outcomes so that researchers can be better informed on the impact of devices, Rickert said.
The UDI is a part of the FDA's broader strategy to create a National Evaluation System for Healthcare Technology, supported by numerous public-private partnerships and many researchers, said Linda Sigg, the FDA's associate director for informatics in the Office of Surveillance and Biometrics within the FDA Center for Devices and Radiological Health.
